{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["37"],"submitter":["Hannoun-Levi JM"],"pubmed_abstract":["<h4>Purpose</h4>To report the results of the <i>Single Fraction Early Prostate Irradiation</i> (SiFEPI) phase 2 prospective trial.<h4>Materials/methods</h4>The SiFEPI trial (NCT02104362) evaluated a single fraction of high-dose rate brachytherapy (HDB) for low- (LR) and favorable-intermediate (FIR) risk prostate cancers. After rectal spacer placement, a single fraction of 20 Gy was delivered to the prostate. Oncological outcome (biochemical (bRFS) and local (lRFS) relapses, disease-free (DFS) and overall (OS) survivals and toxicity (acute/late genito-urinary (GU), gastro-intestinal (GI) and sexual (S) toxicities were investigated.<h4>Results</h4>From 03/2014 to 10/2017, 35 pts were enrolled, of whom 33 were evaluable. With a median age of 66 y [46-79], 25 (76 %) and 8 (24 %) pts were LR and FIR respectively. With a MFU of 72.8 months [64-86], 6y-bRFS, lRFS and mRFS were 62 % [45-85], 61 % [44-85] and 93 % [85-100] respectively while 6y-DFS, CSS and OS were 54 % [37-77], 100 % and 89 % [77-100] respectively. Late GU, GI and S toxicities were observed in 11 pts (33 %;18G1), 4 pts (12 %;4G1) and 7 pts (21 %;1G1,5G2,1G3) respectively. Biochemical relapse (BR) was observed in 11 pts (33 %;7LR,4FIR) with a median time interval between HDB and BR of 51 months [24-69]. Nine of these pts (82 %) presented a histologically proven isolated local recurrence.<h4>Conclusions</h4>Long-term results of the SiFEPI trial show that a single fraction of 20 Gy leads to sub-optimal biochemical control for LR/FIR prostate cancers. The late GU and GI toxicity profile is encouraging, leading to consideration of HDB as a safe irradiation technique."],"journal":["Clinical and translational radiation oncology"],"pagination":["64-70"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC9449500"],"repository":["biostudies-literature"],"pubmed_title":["Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial."],"pmcid":["PMC9449500"],"pubmed_authors":["Chand-Fouche ME","Pace-Loscos T","Schiappa R","Hannoun-Levi JM","Pujol N","Gautier M","Gal J"],"additional_accession":[]},"is_claimable":false,"name":"Single fraction of HDR brachytherapy for prostate cancer: Results of the SiFEPI phase II prospective trial.","description":"<h4>Purpose</h4>To report the results of the <i>Single Fraction Early Prostate Irradiation</i> (SiFEPI) phase 2 prospective trial.<h4>Materials/methods</h4>The SiFEPI trial (NCT02104362) evaluated a single fraction of high-dose rate brachytherapy (HDB) for low- (LR) and favorable-intermediate (FIR) risk prostate cancers. After rectal spacer placement, a single fraction of 20 Gy was delivered to the prostate. Oncological outcome (biochemical (bRFS) and local (lRFS) relapses, disease-free (DFS) and overall (OS) survivals and toxicity (acute/late genito-urinary (GU), gastro-intestinal (GI) and sexual (S) toxicities were investigated.<h4>Results</h4>From 03/2014 to 10/2017, 35 pts were enrolled, of whom 33 were evaluable. With a median age of 66 y [46-79], 25 (76 %) and 8 (24 %) pts were LR and FIR respectively. With a MFU of 72.8 months [64-86], 6y-bRFS, lRFS and mRFS were 62 % [45-85], 61 % [44-85] and 93 % [85-100] respectively while 6y-DFS, CSS and OS were 54 % [37-77], 100 % and 89 % [77-100] respectively. Late GU, GI and S toxicities were observed in 11 pts (33 %;18G1), 4 pts (12 %;4G1) and 7 pts (21 %;1G1,5G2,1G3) respectively. Biochemical relapse (BR) was observed in 11 pts (33 %;7LR,4FIR) with a median time interval between HDB and BR of 51 months [24-69]. Nine of these pts (82 %) presented a histologically proven isolated local recurrence.<h4>Conclusions</h4>Long-term results of the SiFEPI trial show that a single fraction of 20 Gy leads to sub-optimal biochemical control for LR/FIR prostate cancers. The late GU and GI toxicity profile is encouraging, leading to consideration of HDB as a safe irradiation technique.","dates":{"release":"2022-01-01T00:00:00Z","publication":"2022 Nov","modification":"2024-11-21T01:23:05.699Z","creation":"2024-11-21T01:23:05.699Z"},"accession":"S-EPMC9449500","cross_references":{"pubmed":["36093342"],"doi":["10.1016/j.ctro.2022.08.007"]}}